Neoadjuvant immunotherapy before surgery for non-small cell lung cancer
Official title: Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT07166003 · Data updated 2026-11-12
This project will see if giving immunotherapy before surgery helps adults with non‑small cell lung cancer and whether pneumonectomy, lobectomy, or non‑surgical treatments lead to better long‑term outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | April 20, 2025 |
| Main results expected | February 2, 2027 |
| Study ends | April 14, 2030 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07166003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–79 with non‑small cell lung cancer who have received at least two cycles of neoadjuvant immunotherapy, have ECOG 0, and have complete clinical and imaging data are the ideal candidates.
✕Probably not a fit
People with active autoimmune disease, EGFR/ALK‑sensitive mutations, prior chemotherapy or radiotherapy, organ transplantation, severe lung disease, uncontrolled diabetes or hypertension, or who are pregnant or breastfeeding are unlikely to be included and may not benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adults with non‑small cell lung cancer who receive at least two cycles of neoadjuvant immunotherapy and records their subsequent treatments and outcomes. Participants undergo different post‑immunotherapy management—pneumonectomy, lobectomy, or radiotherapy—and investigators will compare long‑term clinical outcomes such as survival, recurrence, and lung function. Eligibility is limited to patients aged 18–79 with ECOG 0 and complete clinical and imaging data, while those with active autoimmune disease, EGFR/ALK‑sensitive mutations, prior anti‑tumor therapy, or severe comorbidities are excluded. The study uses routine clinical data and longitudinal follow‑up to identify differences between surgical approaches and between surgical and non‑surgical modalities after neoadjuvant immunotherapy.
Why it matters
Potential benefit: If successful, the results could help doctors choose the best surgical approach or decide between surgery and non‑surgical options after neoadjuvant immunotherapy, potentially improving survival and quality of life.
How similar studies have gone: Prior neoadjuvant immunotherapy trials in NSCLC have shown encouraging tumor responses and pathologic downstaging, but head‑to‑head observational comparisons of pneumonectomy versus lobectomy or surgery versus radiotherapy after such therapy remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 18 and 79 years; 2. Received at least two cycles of neoadjuvant immunotherapy; 3. ECOG performance status score of 0; 4. Complete clinical information including imaging data available. Exclusion Criteria: 1. Diagnosed with or suspected active autoimmune diseases; 2. Presence of EGFR/ALK sensitive mutations; 3. Pregnant or breastfeeding women; 4. Previous anti-tumor therapies including chemotherapy or radiotherapy; 5. History of organ transplantation or hematopoietic stem cell transplantation; 6. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema; 7. Uncontrolled diabetes mellitus; 8. Uncontrolled hypertension.
Where it's running
-
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China Recruiting
Study contacts
- Study coordinator: Shugeng Gao, MD
- Email: gaoshugeng@cicams.ac.cn
- Phone: 8610-87788177
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ivonescimab alone or with carboplatin/pemetrexed for advanced NSCLC with actionable alterations
This trial tests if ivonescimab, alone or with chemotherapy, can shrink tumors in advanced NSCLC patients who have actionable genomic alterations after prior targeted therapies.
-
MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC
This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.
-
PULSAR radiotherapy plus immunotherapy for high-risk advanced liver cancer
This study tests whether adding PULSAR radiotherapy to standard immunotherapy helps adults with high‑risk advanced liver cancer live longer without their cancer progressing.
-
FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum
Aims to see if adding targeted radiotherapy and cadonilimab immunotherapy to standard second-line chemotherapy helps adults with colorectal cancer that’s spread only to the peritoneum.
-
Personalized exercise plan for cancer survivors
This study tests a personalized, physician-guided exercise program for adults who have completed cancer treatment, to see if a safe, structured plan can be implemented in routine care.
-
Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in Localized Rectal Cancer
In people with locally advanced, treatment-naive rectal cancer, this study tests whether adding two immunotherapy drugs to a standard chemotherapy after short-course radiotherapy can improve tumor response.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.